Kirigia Joses M, Wambebe Charles, Baba-Moussa Amido
World Health Organization, Regional Office for Africa, Brazzaville, Congo.
BMC Med Ethics. 2005 Oct 20;6:E10. doi: 10.1186/1472-6939-6-10.
The Regional Committee for Africa of the World Health Organization (WHO) in 2001 expressed concern that some health-related studies undertaken in the Region were not subjected to any form of ethics review. In 2003, the study reported in this paper was conducted to determine which Member country did not have a national research ethics committee (REC) with a view to guiding the WHO Regional Office in developing practical strategies for supporting those countries.
This is a descriptive study. The questionnaire was prepared and sent by diplomatic pouch to all the 46 Member States in the WHO African Region, through the WHO country representatives, for facilitation and follow up. The data were entered in Excel spreadsheet and subsequently exported to STATA for analysis. A Chi-Squared test (chi2) for independence was undertaken to test the relationship between presence/absence of Research Ethics Committee (REC) and selected individual socioeconomic and health variables.
The main findings were as follows: the response rate was 61% (28/46); 64% (18/28) confirmed the existence of RECs; 36% (10/28) of the respondent countries did not have a REC (although 80% of them reported that they had in place an ad hoc ethical review mechanism); 85% (22/26) of the countries that responded to this question indicated that ethical approval of research proposals was, in principle, required; and although 59% of the countries that had a REC expected it to meet every month, only 44% of them reported that the REC actually met on a monthly basis. In the Chi-Squared test, only the average population in the group of countries with a REC was statistically different (at 5% level of significance) from that of the group of countries without a REC.
In the current era of globalized biomedical research, good ethics stewardship demands that every country, irrespective of its level of economic development, should have in place a functional research ethics review system in order to protect the dignity, integrity and safety of its citizens who participate in research.
2001年，世界卫生组织（WHO）非洲区域委员会对该区域开展的一些与健康相关的研究未经过任何形式的伦理审查表示关切。2003年，开展了本文所报告的研究，以确定哪些成员国没有国家研究伦理委员会（REC），从而指导WHO区域办事处制定支持这些国家的切实可行战略。
这是一项描述性研究。问卷通过外交邮袋发送给WHO非洲区域的所有46个成员国，由WHO国家代表协助并跟进。数据录入Excel电子表格，随后导出到STATA进行分析。采用独立性卡方检验（chi2）来检验研究伦理委员会（REC）的有无与选定的个体社会经济和健康变量之间的关系。
主要研究结果如下：回复率为61%（28/46）；64%（18/28）确认存在REC；36%（10/28）的受访国家没有REC（尽管其中80%报告称已建立临时伦理审查机制）；85%（22/26）回答该问题的国家表示原则上要求对研究提案进行伦理批准；尽管59%有REC的国家期望其每月开会，但只有44%报告称REC实际每月开会。在卡方检验中，只有有REC的国家组的平均人口与没有REC的国家组在统计学上有差异（在5%的显著性水平）。
在当前全球化生物医学研究时代，良好的伦理管理要求每个国家，无论其经济发展水平如何，都应建立一个有效的研究伦理审查系统，以保护参与研究的公民的尊严、完整性和安全。
